LEVETIRACETAM tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

levetiracetam (UNII: 44YRR34555) (levetiracetam - UNII:44YRR34555)

Հասանելի է:

Dr. Reddy's Laboratories Limited

INN (Միջազգային անվանումը):

levetiracetam

Կազմը:

levetiracetam 1000 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. None. Levetiracetam levels may decrease during pregnancy [see Warnings and Precautions (5.9) ]. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fet

Ապրանքի ամփոփագիր:

Levetiracetam tablets USP, 1000 mg are beige, oval shaped, biconvex, film coated tablets debossed with '248' on one side and 'RDY' on other side, 'RD' and 'Y' separated with bisect line. They are supplied in bottles of 30's, 60's, 100's, 500's and unit dose package of 10 (1 x 10). Bottles of 30                                                               NDC 55111-248-30 Bottles of 60                                                               NDC 55111-248-60 Bottles of 100                                                             NDC 55111-248-01 Bottles of 500                                                             NDC 55111-248-05 Unit dose package of 10 (1 x 10)                                  NDC 55111-248-79 Pharmacist: Dispense in a tight light-resistant container with a child-resistant closure. Store levetiracetam tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

Dr. Reddy's Laboratories Limited
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MEDICATION GUIDE
Levetiracetam Tablets USP, 1000 mg
Read this Medication Guide before you start taking levetiracetam
tablets and each time you get a refill.
There may be new information. This information does not take the place
of talking to your healthcare
provider about your medical condition or treatment.
What is the most important information I should know about
levetiracetam tablets?
Like other antiepileptic drugs, levetiracetam tablets may cause
suicidal thoughts or actions in a very small
number of people, about 1 in 500 people taking it.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
Do not stop levetiracetam tablets without first talking to a
healthcare provider.
•
Stopping levetiracetam tablets suddenly can cause serious problems.
Stopping a seizure medicine
suddenly can cause seizures that will not stop (status epilepticus).
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other
causes.
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
•
Call your healthcare provider between visits as needed, especially if
you are worried about
symptoms.
What are levetiracetam tablets?
Levetiracetam tablets are a prescription medicine taken by mouth that
is used with other medicines to
tre

Ապրանքի հատկությունները

LEVETIRACETAM- LEVETIRACETAM TABLET
DR. REDDY'S LABORATORIES LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAMSAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LEVETIRACETAM.
LEVETIRACETAM TABLETS USP , FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indications and Usage, Partial Onset Seizures (1.1) [12/2011]
Dosage and Administration, Partial Onset Seizures (2.1,2.2, 2.5)
[12/2011]
Warnings and Precautions (5.1, 5.3, 5.4, 5.7, 5.8, 5.9) [12/2011]
INDICATIONS AND USAGE
Levetiracetam tablets are an antiepileptic drug indicated for
adjunctive therapy in the treatment of:
Partial onset seizures in patients one month of age and older with
epilepsy (1.1)
Myoclonic seizures in patients 12 years of age and older with juvenile
myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age
and older with idiopathic generalized epilepsy (1.3)
DOSAGE AND ADMINISTRATION
Use the oral solution for pediatric patients with body weight ≤ 20
kg (2.1).
For pediatric patients, use weight-based dosing for the oral solution
with a calibrted measuring device (not a household
teaspoon or tablespoon) (2.1)
_Partial Onset Seizures_
1 Month To < 6 Months: 7 mg/kg twice daily, increase in increments of
7 mg/kg twice daily every 2 weeks to
recommended dose of 21 mg/kg twice daily (2.2)
6 Months To < 4 Years: 10 mg/kg twice daily, increase in increments of
10 mg/kg twice daily every 2 weeks to
recommended dose of 25 mg/kg twice daily (2.2)
4 Years To < 16 Years: 10 mg/kg twice daily, increase in increments of
10 mg/kg twice daily every 2 weeks to
recommended dose of 30 mg/kg twice daily (2.2)
Adults 16 Years And Older: 500 mg twice daily, increase as needed and
tolerated in increments of 500 mg twice daily
every 2 weeks to a maximum recommended dose of 1500 mg twice daily
(2.2)
_Myoclonic Seizures In Adults and Pediatric Patients 12 Years And
Older_
500 mg twice daily, increase by 500 mg twice dail